Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT03518567
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Behavioral Economic Analysis of Demand for Marijuana
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008385', 'term': 'Marijuana Smoking'}], 'ancestors': [{'id': 'D000074609', 'term': 'Marijuana Use'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073847', 'term': 'Smoking, Non-Tobacco Products'}, {'id': 'D012907', 'term': 'Smoking'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013759', 'term': 'Dronabinol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth_aston@brown.edu', 'phone': '401-863-6668', 'title': 'Elizabeth Aston, PhD', 'organization': 'Brown University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])\n\nSmoked marijuana cigarettes: High THC dose (6% THC): Smoked marijuana cigarettes (High THC dose \\[6% THC\\])', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Validity of the Marijuana Purchase Task (MPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])\n\nSmoked marijuana cigarettes: High THC dose (6% THC): Smoked marijuana cigarettes (High THC dose \\[6% THC\\])'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.00000004', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.78', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.\n\ncovariate: baseline total individual income'}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of the experimental session (i.e., 60 minutes)', 'description': 'The Marijuana Purchase Task will be used to collect data on marijuana demand. Participants indicate how much marijuana they would purchase at varying levels of price (e.g., free - $60). Indices of marijuana demand are derived from the task and used to determine the relative value of marijuana for each participant. Hits purchased on the MPT will correspond with actual number of hits purchased and smoked in the laboratory. Primary outcome is percentage of participants who purchased and smoked exactly what they said they would.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed Session 1 (n=101), reported purchasing at least 1 hit from a cannabis joint at their randomly selected price-point on the Marijuana Purchase Task (n=90), and chose to smoke during the Session (n=86) were included in the analysis. Outcome corresponds to percentage of participants who smoked exactly what they said they would.'}, {'type': 'SECONDARY', 'title': 'Change in Marijuana Craving Questionnaire (MCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])\n\nSmoked marijuana cigarettes: High THC dose (6% THC): Smoked marijuana cigarettes (High THC dose \\[6% THC\\])'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.000000009', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.75', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.09', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours', 'description': 'Subjective marijuana craving was assessed via a 10-item Marijuana Craving Questionnaire. Participants were asked to respond to items according to how they were thinking or feeling "right now," and MCQ items were rated on a 1 = "strongly disagree" to 7 = "strongly agree" scale, with higher scores indicating greater subjective marijuana craving, and summed to yield a total craving score. Total craving score was used in analyses.', 'unitOfMeasure': 'units on the MCQ', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed Session 1 (n=101), reported purchasing at least 1 hit from a cannabis joint at their randomly selected price-point on the Marijuana Purchase Task (n=90), and chose to smoke during the Session (n=86) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Marijuana Smoking Topography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])\n\nSmoked marijuana cigarettes: High THC dose (6% THC): Smoked marijuana cigarettes (High THC dose \\[6% THC\\])'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '13.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.87', 'groupIds': ['OG000'], 'paramType': 'correlation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.02', 'statisticalMethod': 'correlation', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Correlation between puffs on the topography device and grams of cannabis used per week.'}], 'paramType': 'MEAN', 'timeFrame': 'Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.', 'description': 'Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The outcome measure is number of puffs.', 'unitOfMeasure': 'puffs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed Session 2 with usable smoking topography data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}]}, {'type': 'Completed Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': 'Completed Session 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Completed Session 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'comment': 'This is the number of participants who completed Baseline, Session 1, and Session 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'High THC Dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])\n\nSmoked marijuana cigarettes: High THC dose (6% THC): Smoked marijuana cigarettes (High THC dose \\[6% THC\\])'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-08', 'size': 229551, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-08T19:26', 'hasProtocol': True}, {'date': '2020-10-08', 'size': 168119, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-24T15:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2018-04-09', 'resultsFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-07', 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of the Marijuana Purchase Task (MPT)', 'timeFrame': 'Duration of the experimental session (i.e., 60 minutes)', 'description': 'The Marijuana Purchase Task will be used to collect data on marijuana demand. Participants indicate how much marijuana they would purchase at varying levels of price (e.g., free - $60). Indices of marijuana demand are derived from the task and used to determine the relative value of marijuana for each participant. Hits purchased on the MPT will correspond with actual number of hits purchased and smoked in the laboratory. Primary outcome is percentage of participants who purchased and smoked exactly what they said they would.'}], 'secondaryOutcomes': [{'measure': 'Change in Marijuana Craving Questionnaire (MCQ)', 'timeFrame': 'The MCQ will be administered pre- and post- marijuana smoking during the experimental session, up to 6 hours', 'description': 'Subjective marijuana craving was assessed via a 10-item Marijuana Craving Questionnaire. Participants were asked to respond to items according to how they were thinking or feeling "right now," and MCQ items were rated on a 1 = "strongly disagree" to 7 = "strongly agree" scale, with higher scores indicating greater subjective marijuana craving, and summed to yield a total craving score. Total craving score was used in analyses.'}, {'measure': 'Marijuana Smoking Topography', 'timeFrame': 'Marijuana smoking topography indices will be collected during the 1-hour ad libitum marijuana smoking topography experimental session.', 'description': 'Indices of Marijuana Smoking Topography will be obtained during the experimental session. Participants will smoke marijuana through a smoking topography device. The outcome measure is number of puffs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Marijuana Smoking']}, 'descriptionModule': {'briefSummary': 'This laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.', 'detailedDescription': 'This laboratory study will employ a multi-session experimental design to examine craving for marijuana, the effect of marijuana administration (High THC) on behavioral economic demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly. The relationship between hypothetical and actual demand for marijuana will be examined. We will also investigate relationship between demand for marijuana and indices of marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly to obtain a final sample of 85 with complete data (15% of attrition). Participants will be tested at a baseline session and during two experimental sessions (an ad libitum marijuana smoking session and a marijuana smoking topography session). This study will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid tool for assessing behavioral economic marijuana demand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* marijuana use at least 8 times in the past month on average and at least monthly for the past 6 months\n* English-speaking\n* negative urine toxicology screen for drugs other than marijuana\n* non-treatment seeking\n* purchase of marijuana at least twice in the past 6 months to confirm familiarity with the construct to be measured\n\nExclusion Criteria:\n\n* positive pregnancy test\n* nursing\n* inability to use contraception during the study\n* poor physical health\n* positive breath alcohol concentration\n* diagnosis of a current affective disorder, psychosis, and panic disorder\n* self-report of past serious adverse reaction to marijuana\n* current psychotropic drug use\n* smoking more than 20 tobacco cigarettes per day\n* inability to abstain from marijuana for 15 hours\n* body mass index outside 18.5-30 kg/m2 range'}, 'identificationModule': {'nctId': 'NCT03518567', 'briefTitle': 'Behavioral Economic Analysis of Demand for Marijuana', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Behavioral Economic Analysis of Demand for Marijuana', 'orgStudyIdInfo': {'id': '#1502001185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High THC dose (6% THC)', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])', 'interventionNames': ['Drug: Smoked marijuana cigarettes: High THC dose (6% THC)']}], 'interventions': [{'name': 'Smoked marijuana cigarettes: High THC dose (6% THC)', 'type': 'DRUG', 'description': 'Smoked marijuana cigarettes (High THC dose \\[6% THC\\])', 'armGroupLabels': ['High THC dose (6% THC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Elizabeth Aston, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elizabeth Aston', 'investigatorAffiliation': 'Brown University'}}}}